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Hepatitis

Hepatitis is a gastroenterological disease, featuring inflammation of the liver. The clinical signs and prognosis, as well as the therapy, depend on the cause. more...

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Signs and symptoms

Hepatitis is characterised by fatigue, malaise, joint aches, abdominal pain, vomiting 2-3 times per day for the first 5 days, loss of appetite, dark urine, fever, hepatomegaly (enlarged liver) and jaundice (icterus). Some chronic forms of hepatitis show very few of these signs and only present when the longstanding inflammation has led to the replacement of liver cells by connective tissue; the result is cirrhosis. Certain liver function tests can also indicate hepatitis.

Types of hepatitis

Viral

Most cases of acute hepatitis are due to viral infections:

  • Hepatitis A
  • Hepatitis B
  • Hepatitis C
  • D-agent (requires presence of the hepatitis B virus)
  • Hepatitis E
  • Hepatitis F (discredited)
  • Hepatitis G
Please see the respective articles for more detailed information

Hepatitis A

Hepatitis A is an enterovirus transmitted by the orofecal route, such as contaminated food. It causes an acute form of hepatitis and does not have a chronic stage. The patient's immune system makes antibodies against Hepatitis A that confer immunity against future infection. People with Hepatitis A are usually advised to rest, stay hydrated and avoid alcohol. A vaccine is available that will prevent infection from hepatitis A for life.

Hepatitis B

Hepatitis B causes both acute and chronic hepatitis in some patients who are unable to eliminate the virus. Identified methods of transmission include blood (blood transfusion, now rare), tattoos (both amateur and professionally done), sexually or vertically (from mother to her unborn child). However, in about half of cases the source of infection cannot be determined. Blood contact can occur by sharing syringes in intravenous drug use, shaving accessories such as razor blades, or touching wounds on infected persons. Needle-exchange programmes have been created in many countries as a form of prevention. In the United States, 95% of patients clear their infection and develop antibodies against Hepatitis B virus. 5% of patients do not clear the infection and develop chronic infection; only these people are at risk of long term complications of Hepatitis B. Patients with chronic hepatitis B have antibodies against Hepatitis B, but these antibodies are not enough to clear the infection that establishes itself in the DNA of the affected liver cells. The continued production of virus combined with antibodies is a likely cause of immune complex disease seen in these patients. A vaccine is available that will prevent infection from hepatitis B for life. Hepatitis B infections result in 500,000 to 1,200,000 deaths per year worldwide due to the complications of chronic hepatitis, cirrhosis, and hepatocellular carcinoma. Hepatitis B is endemic in a number of (mainly South-East Asian) countries, making cirrhosis and hepatocellular carcinoma big killers. There are three, FDA-approved treatment options available for persons with a chronic hepatitis B infection: alpha-interferon, adefovir and lamivudine. In about 45% of persons on treatment achieve a sustained response.

Read more at Wikipedia.org


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Migenix Initiates Enrollment In Phase Iib Hepatitis Trial
From Worldwide Biotech, 1/1/06

MIGENIX Inc. (TSX: MGI; OTC: MGIFF), a clinical-stage developer of drugs for infectious and degenerative diseases, has initiated enrollment in a Phase IIb combination therapy clinical trial of celgosivir (MX-3253), supported in part through an agreement with Schering-Plough. Celgosivir is an orally administered, first-in-class alpha glucosidase 1 inhibitor, in development for the treatment of chronic hepatitis C virus (HCV) infections. Results of the study are anticipated in mid-calendar 2006.

Jim DeMesa, M.D., president and CEO of MIGENIX stated, "With the large market potential and unmet need in current hepatitis C treatment, celgosivir is an important component of our value proposition in the short-term. Based on its strong demonstration of synergy in non-clinical studies to date, celgosivir shows great promise as part of a combination therapy approach to improving the success of treatment for patients suffering from chronic hepatitis C infections."

About MX-3253 and the Phase IIb Combination Study

MX-3253 (celgosivir) is an alpha-glucosidase I inhibitor and is currently the only oral anti-HCV drug in clinical development that acts through host- directed glycosylation. In preclinical studies, celgosivir has demonstrated strong synergy with interferon-alpha with and without ribavirin and has the potential to be included as part of a combination therapeutic approach to improve efficacy and/or tolerability. A recently completed Phase IIa monotherapy study demonstrated that celgosivir was well tolerated with some evidence of antiviral activity in treatment-naive chronic HCV patients.

The Phase IIb combination study of MX-3253 is a randomized, multi-center, active-controlled, 12 week evaluation of MX-3253 in three treatment arms of up to 20 chronic HCV "non-responder" patients each: celgosivir plus peginterferon alfa-2b plus ribavirin (3-way combination); celgosivir plus peginterferon

alfa-2b (2-way combination); and placebo plus peginterferon alfa-2b plus ribavirin (control). An agreement was completed in July with Schering-Plough Corporation where they are contributing (a) the supply of PEGETRON(TM) (peginterferon alfa-2b powder for solution plus ribavirin 200 mg capsules) and (b) certain technical and laboratory support and other services for the study. In addition, the agreement grants Schering-Plough limited periods of exclusivity for data review of clinical trial results and for the negotiation of a license agreement.

Patients for the Phase IIb study will be selected based on having genotype 1 chronic HCV and having failed to respond to pegylated alpha interferon plus ribavirin therapy (non-responders). Today, there are very limited treatment options for the approximately 50% of HCV patients who have failed treatment with the current standard of care, pegylated interferon plus ribavirin.

About HCV

HCV, the most common chronic blood-borne infection in the United States, causes inflammation of the liver and may progress to more serious complications such as cirrhosis of the liver, liver cancer and death. Approximately 2.7 million people in the United States are chronically infected with HCV, and the Centers for Disease Control and Prevention (CDC) estimates that by the year 2010, the number of deaths attributed annually to HCV could surpass that due to HIV/AIDS in the US. Worldwide, the World Health Organization estimates that 170 million individuals carry chronic HCV infection, with 3 to 4 million new infections each year.

Therapy for HCV currently employs a drug combination approach, which is anticipated to continue in the future. The current standard of care for chronic hepatitis C is pegylated interferon combined with ribavirin, which fails to provide a satisfactory outcome for approximately 50% of patients infected with HCV genotype 1. In addition, these drugs can cause significant side effects that limit tolerance to therapy, or a frequent lack of sustained treatment response.

About MIGENIX

MIGENIX is committed to advancing therapy, improving health, and enriching life by developing and commercializing drugs in the areas of infectious and degenerative diseases. The company's clinical programs include drug candidates for the treatment of chronic hepatitis C infections (Phase II), the prevention of catheter-related infections (Phase III), the treatment of neurodegenerative diseases (Phase I) and the treatment of acne (Phase II). MIGENIX is headquartered in Vancouver, British Columbia, Canada with US operations in San Diego, California.

For more information, visit http://www.migenix.com or call 604/221-9666 Ext. 241,

COPYRIGHT 2006 Worldwide Videotex
COPYRIGHT 2005 Gale Group

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